اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BANZEL از شرکت EISAI INC
New Drug Application (NDA): 021911
Company: EISAI INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BANZEL | RUFINAMIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| BANZEL | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| BANZEL | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/14/2008 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021911lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/28/2019 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021911Orig1s017,201367Orig1s008ltr.pdf |
||
| 06/17/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2015 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s013,201367Orig1s005ltr.pdf |
||
| 02/12/2015 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s012,201367Orig1s003ltr.pdf |
||
| 06/06/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2011 | SUPPL-8 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021911s008,201367s001ltr.pdf |
|
| 03/03/2011 | SUPPL-7 | REMS-Modified |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201367s000,021911s007ltr.pdf |
||
| 11/08/2010 | SUPPL-5 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021911s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021911s005ltr.pdf |
||
| 10/16/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021911s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/28/2019 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf | |
| 06/25/2015 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf | |
| 06/25/2015 | SUPPL-13 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf | |
| 06/25/2015 | SUPPL-13 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf | |
| 02/12/2015 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf | |
| 03/03/2011 | SUPPL-7 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf | |
| 11/08/2010 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021911s005lbl.pdf | |
| 11/14/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021911lbl.pdf |
BANZEL
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BANZEL | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 021911 | EISAI INC |
| RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 205075 | GLENMARK PHARMS LTD |
| RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204993 | HETERO LABS LTD III |
| RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204988 | HIKMA PHARMS |
| RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 205095 | MYLAN |
TABLET;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BANZEL | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | Yes | AB | 021911 | EISAI INC |
| RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 205075 | GLENMARK PHARMS LTD |
| RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 204993 | HETERO LABS LTD III |
| RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 204988 | HIKMA PHARMS |
| RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 205095 | MYLAN |
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